Methods of Treating Peripheral T Cell Lymphoma Using Anti-CD30 Antibody Drug Conjugate Therapy
The present disclosure, relates, in general to methods treating peripheral T cell lymphoma and who are receiving treatment with an anti-CD30 antibody drug conjugate in combination with accompanying chemotherapy.
1 . A method for treating a subject having a peripheral T cell lymphoma (PTCL) comprising administering a composition comprising an anti-CD30 antibody drug conjugate every three weeks in combination with a chemotherapy consisting essentially of cyclophosphamide, doxorubicin and prednisone (CHP).
2 . The method of claim 1 wherein the PTCL is selected from the group consisting of systemic anaplastic large cell lymphoma (sALCL), angioimmunoblastic T-cell lymphoma (AITL), peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), Adult T-Cell Leukemia/Lymphoma (ATLL), Enteropathy-associated T-cell lymphoma (EATL) and Hepatosplenic T-cell lymphoma.
3 . The method of claim 1 wherein the PTCL is a sALCL.
4 . The method of claim 3 wherein the sALCL is selected from the group consisting of anaplastic lymphoma kinase positive (ALK+) sALCL and anaplastic lymphoma kinase negative (ALK−) sALCL.
5 . (canceled)
6 . The method of claim 1 wherein the PTCL is not a sALCL or wherein the PTCL is not an AITL.
7 . The method of claim 1 wherein the PTCL is selected from the group consisting of angioimmunoblastic T-cell lymphoma (AITL), peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), Adult T-Cell Leukemia/Lymphoma (ATLL), Enteropathy-associated T-cell lymphoma (EATL) and Hepatosplenic T-cell lymphoma, systemic anaplastic large cell lymphoma (sALCL), peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), Adult T-Cell Leukemia/Lymphoma (ATLL), Enteropathy-associated T-cell lymphoma (EATL) and Hepatosplenic T-cell lymphoma.
8 - 10 . (canceled)
11 . The method of claim 1 , wherein the subject has not previously been treated for a hematologic cancer, or wherein the subject has previously been treated for a hematologic cancer and the cancer has relapsed or is refractory.
12 . (canceled)
13 . The method of claim 1 , wherein the PTCL is a stage III or stage IV PTCL.
14 . The method of claim 1 wherein the PTCL is a CD30-expressing PTCL.
15 - 16 . (canceled)
17 . The method of claim 1 wherein the combination therapy is administered every three weeks.
18 . The method of claim 17 wherein the combination therapy is administered on day 1 of a 21 day cycle.
19 . The method of claim 17 wherein the combination therapy is administered for no more than six to eight cycles.
20 . (canceled)
21 . The method of claim 17 wherein the subject receives single-agent anti-CD30 antibody drug conjugate for eight to 10 additional cycles for a total of 16 cycles.
22 . The method of claim 1 wherein the anti-CD-30 antibody drug conjugate is administered at a dose of 1.8 mg/kg.
23 . (canceled)
24 . The method of claim 1 wherein the anti-CD30 antibody of the anti-CD30 antibody drug conjugate comprises
i) a heavy chain CDR1 set out in SEQ ID NO: 4, a heavy chain CDR2 set out in SEQ ID NO: 6, a heavy chain CDR3 set out in SEQ ID NO: 8; and
ii) a light chain CDR1 set out in SEQ ID NO: 12, a light chain CDR2 set out in SEQ ID NO: 14, and a light chain CDR13 set out in SEQ ID NO: 16.
25 . The method of claim 1 wherein the anti-CD30 antibody of the anti-CD30 antibody drug conjugate comprises
i) an amino acid sequence at least 85% identical to a heavy chain variable region set out in SEQ ID NO: 2 and
ii) an amino acid sequence at least 85% identical to a light chain variable region set out in SEQ ID NO: 10.
26 - 30 . (canceled)
31 . The method of claim 1 wherein the anti-CD30 antibody drug conjugate is brentuximab vedotin.
32 . The method of claim 1 wherein the anti-CD30 antibody drug conjugate is brentuximab vedotin and is administered at 1.8 mg/kg, cyclophosphamide is administered at 750 mg/m 2 , doxorubicin is administered at 50 mg/m 2 , and prednisone is administered at 100 mg on days 1 to 5 of a 21 day cycle.